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TruGraf® Long-term Clinical Outcomes Study

NCT04491552 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2022-11-14

No results posted yet for this study

Summary

This is a prospective, multi-center, observational study. Subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at study enrollment and thereafter every 3 months. In addition subjects will have OmniGraf™ (TruGraf® and TRAC™) testing at any time there is a clinical suspicion of acute rejection. Data collection for the primary objective extends over a 2-year period.

Conditions

  • Kidney Transplant Rejection

Interventions

DIAGNOSTIC_TEST

Patients monitored with TruGraf and TRAC testing

This is an observational study there are no protocol mandated interventions. TruGraf and TRAC results will be utilized in conjunction with standard of care assessments to determine patient management.

Sponsors & Collaborators

  • Transplant Genomics, Inc.

    lead INDUSTRY

Principal Investigators

  • Patty W. Thielke, PharmD · Transplant Genomics, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-09
Primary Completion
2023-09-30
Completion
2023-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04491552 on ClinicalTrials.gov